Handling of Out of Calibration Equipments and Instruments

Handling Out of calibration instruments

• When any instrument is found to be out of tolerance then it should be immediately notified to the supervisor or the person responsible
• The calibration data is to be reviewed to verify the validity of out of tolerance
• Investigation is to be done on the root cause of out of calibration instruments
• Historical data can be reviewed which can provide the factors leading to the root cause
• Corrective and preventive action should be initiated regarding the instrument in terms of replacement or re calibration or repair or removal from operation
• Notification regarding out of calibration should be given to owner or supervisor responsible for the instrument
• The notification should include current calibration data, range of error and date of last calibration which was successful
• The supervisor evaluates the root cause and its effect on quality of the product
• The effect on quality of the product is evaluated based on the standard operating procedure which defines the quality standards
• When initiating the CAPA supervisor should consider the process requirements which are measured by the instrument
• Major decisions which are taken regarding its effect on quality should be approved by quality department and also be documented
• The subsequent events should be observed. The complete process should be documented which can be useful in the future when similar problem arises.
• Change control can be initiated which may require re execution or re calibration of instruments installation, operational and performance qualification
• Proper review should be done with approval of quality departments

Handling Out of calibration Equipment’s

• When equipment’s are mishandled or overloaded then they show defective results or which fall out of specified limits.
• The equipment which is out of specified limits is isolated and labeled to avoid using it until repaired properly
• Root cause analysis is done and CAPA is initiated
• Personnel in the laboratory should test the effects if there is any malfunctioning and implement corrective and preventive action
• The calibration data is checked as to how much product is tested or inspected?
• If the equipment is suspected of producing results out of specifications then the product should be tested?
• If the product is already shipped then supervisor should have a plan of action on how they recall the product? 
• When the equipment failure is not in proportion to its function then such case of failure may be attributed by peripheral equipment
• Before using the equipment again it should be tested again for producing correct results

Other considerations  

• Even if it is an instrument or equipment proper procedures should be followed according to the SOP.
• Records should be maintained along with the identification number of equipment or instrument.
• Manufacturers name, identification type, serial number and unique identification number should be included in the report
• Calibration should be in compliance with SOPs
• Instructions given by the manufacturer
• Dates and results of calibration or verification done to equipment or instrument
• Historical data regarding their malfunction, modification or repair
• Depending on the type of instruments or equipment’s they should be protected from fungal or microbial growth and should not be stored at extreme temperature or humidity
• They should be protected to resist corrosion

Out of calibration equipments, instruments, root cause analysis, capa, calibration

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